FDA Approval for New Defibrillators and Heart Failure Devices

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the DYNAGEN MINI and INOGEN MINI ICDs, as well as the DYNAGEN X4 and INOGEN X4 CRT-Ds.

The X4 line of quadripolar CRT-Ds offers 70 percent more pacing options to address high capture thresholds and phrenic nerve stimulation effectively, along with the largest battery capacity in the industry. These newly approved devices continue the Boston Scientific history of industry-leading projected longevity and a six-year CRT-D warranty.

Extending the Boston Scientific portfolio of defibrillators, the ICDs in the MINI family are the world's smallest and thinnest devices and are designed for patient comfort. The small dimensions of the MINI ICD are up to 20 percent smaller by volume and up to 24 percent thinner than competitive devices from other manufacturers.[i]

"The tiny size of the MINI ICD provides a real benefit to some patients, in particular those with a smaller frame," said Prof. Dr. Hans-Joachim Trappe from University Marien Hospital Herne, Hospital of Ruhr-University, Bochum, Germany. "The MINI ICD not only improves patient comfort, but also provides these patients with innovative technology to help treat life-threatening arrhythmias of the heart."

"With these new devices and our current line of long-lasting ICDs and CRT-Ds, including the world's only subcutaneous ICD, we believe we offer the very best range of options for patients at risk of sudden cardiac arrest with or without the need for cardiac resynchronization therapy," said Joe Fitzgerald, executive vice president and president for the Rhythm Management division of Boston Scientific. "Our devices simply offer more options to improve outcomes, reduce complications and lower the costs of treating patients."

ICDs and CRT-Ds are designed to treat patients suffering from heart failure and/or to provide protection to patients at risk of sudden cardiac death. Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's need for blood and oxygen.[ii] Sudden cardiac death (SCD) is a sudden, unexpected death caused by loss of heart function and is a leading cause of death. Nearly 400,000 out-of-hospital cardiac arrests occur annually in the United States.[iii]